SCHEIN BACITRACIN- bacitracin zinc ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)

Available from:

Henry Schein, Inc.

INN (International Name):

BACITRACIN ZINC

Composition:

BACITRACIN 500 [iU] in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose: First Aid Antibiotic  First Aid to help prevent infection in minor cuts, burns, scrapes

Authorization status:

OTC monograph final

Summary of Product characteristics

SCHEIN BACITRACIN- BACITRACIN ZINC OINTMENT
HENRY SCHEIN, INC.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may_
_be marketed if they comply with applicable regulations and policies.
FDA has not_
_evaluated whether this product complies._
----------
DRUG FACTS
In Each Gram-Bacitracin Zinc 500 units
In Each Gram-Bacitracin Zinc 500 units
Purpose: First Aid Antibiotic
First Aid to help prevent infection in minor cuts, burns, scrapes
DO NOT USE: In the eyes. Over large areas of the body. If you are
allergic to any of the
ingredients due to the possibility of anaphylactic shock. Longer than
1 week unless
directed by a doctor.
Stop use and ask a doctor before use: in the case of dep puncture
wounds, animal
bites, or serious burns. If the condition persists or gets worse. If a
rash or other
allergic reaction develops.
If swallowed get medical help or contact a Poison Control Center
immediately.
Keep out of the reach of children
Clean the affected area.
Apply a small amount of this product (an amount equal to the surface
area of the tip of
a finger) on the area 1-3 times daily
May be covered with a sterile bandage.
inactive Ingredient: White Petrolatum
SCHEIN BACITRACIN
bacitracin zinc ointment
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:0404-0400
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)
BACITRACIN
500 [iU] in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
PETROLATUM (UNII: 4T6H12BN9U)
PRODUCT CHARACTERISTICS
COLOR
SCORE
SHAPE
SIZE
FLAVOR
IMPRINT CODE
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:0404-0400-
47
144 in 1 CARTON
12/04/2011
1
NDC:0404-0400-
09
0.9 g in 1 PACKET; Type 0: Not a Combination
Product
2
NDC:0404-0400-
48
1 in 1 CARTON
12/04/2011
2
NDC:0404-0400-
28
28 g in 1 TUBE; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMB